FDA Approves Aprepitant to Treat Chemotherapy-Induced Nausea and Vomiting

A second agent in just over 2 weeks was approved by the Food and Drug Administration (FDA) to treat chemotherapy-induced nausea/vomiting (CINV).

Aprepitant (Cinvanti) injectable emulsion will be used in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC), according to Heron Therapeutics, the manufacturer of the P/neurokinin-1 (NK1) receptor antagonist.

“CINV remains a high unmet medical need in the oncology community, and five full days of CINV coverage continues to be our goal,” Jeffrey F. Patton, MD, chief executive officer of Tennessee Oncology, said in a statement. “NK1 receptor antagonists are recommended for routine use with HEC and are a recommended option with MEC. Despite this, NK1 receptor antagonists are underutilized in CINV. This provides a large opportunity for CINVANTI to help more patients avoid CINV and adhere to their chemotherapy regimens.”

Aprepitant is the first-approved NK1 receptor antagonist that does not have polysorbate 80, which frequently causes allergic reactions that may make patients unable to take another anti-emetic.

The approval comes after 2 pivotal randomized, cross-over bioequivalence studies of aprepitant and fosaprepitant (Emend IV)—the bioequivalent of aprepitant—showed subjects receiving aprepitant reported fewer adverse events than those receiving fosaprepitant, including substantially fewer infusion-site reactions. The drug proved to be effective in combatting acute and delayed CINV after patients received HEC or MEC.

“Aprepitant has long been the standard in the NK1 class and it remains the only single-agent NK1 with proven efficacy in preventing CINV in both the acute and delayed phases in HEC and MEC,” said Rudolph M. Navari, MD, PhD, University of Alabama, Birmingham School of Medicine, director, Cancer Care Program, Division of Hematology Oncology. “Because CINVANTI is a novel, polysorbate 80-free IV formulation of aprepitant, it enables physicians to provide patients with standard-of-care efficacy without the potential risk of polysorbate 80-related adverse events, such as infusion-site reactions.”